Adtralza - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Adtralza 150 mg solution for injection in pre-filled syringe

tralokinumab

"V This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Adtralza is and what it is used for

• 2. What you need to know before you use Adtralza

• 3. How to use Adtralza

• 4. Possible side effects

• 5. How to store Adtralza

• 6. Contents of the pack and other information

1. What Adtralza is and what it is used for

Adtralza contains the active substance tralokinumab.

ralokinumab is a monoclonal antibody (a type of protein) that blocks the action of a protein called IL-13. IL-13 plays a major role in causing the symptoms of atopic dermatitis.

Adtralza is used to treat adults with moderate-to-severe atopic dermatitis, also known as atopic eczema. Adtralza may be used with eczema medicines that you apply to the skin or it may be used on its own.

Using Adtralza for atopic dermatitis can improve your eczema and reduce the related itching and skin pain.

2. What you need to know before you use Adtralza

Do not use Adtralza:

• – if you are allergic to tralokinumab or any of the other ingredients of this medicine (listed in

section 6).

If you think you may be allergic, or you are not sure, ask your doctor, pharmacist or nurse for advice before using Adtralza.

Warnings and precautions

alk to your doctor, pharmacist or nurse before using Adtralza.

Allergic reactions

Very rarely, medicines can cause allergic (hypersensitivity) reactions and severe allergic reactions called anaphylaxis. You must look out for signs of these reactions (such as breathing problems,

swelling of the face, mouth, and tongue, fainting, dizziness, feeling lightheaded (because of low blood pressure), hives, itching and skin rash) while you are using Adtralza.

Stop using Adtralza and tell your doctor or get medical help immediately if you notice any signs of an allergic reaction. Such signs are listed under “Serious side effects” in section 4.

Parasitic infection in the intestines

Adtralza may reduce your resistance to infections caused by parasites. Any parasitic infection should be treated before you start treatment with Adtralza. Tell your doctor if you have diarrhoea, gas, upset stomach, greasy stools, and dehydration which could be signs of a parasitic infection. If you live in a region where these infections are common or if you are travelling to such a region, tell your doctor.

Eye problems

Talk to your doctor if you have any new or worsening eye problems, including eye pain or changes in vision.

Children and adolescents

Do not give this medicine to children and adolescents below the age of 18 years because the safety and benefits of Adtralza are not yet known.

Other medicines and Adtralza

Tell your doctor or pharmacist

• – If you are using, have recently used or might use any other medicines.

• – If you have recently had a vaccination or are due to have one.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or you are planning to have a baby, ask your doctor for advice before using this medicine. The effects of Adtralza in pregnant women are not known; therefore, it is preferable to avoid using it during pregnancy unless your doctor advises you to use it.

If applicable, you and your doctor should decide if you will breast-feed or use Adtralza. You should not do both.

Driving and using machines

Adtralza is unlikely to reduce your ability to drive and use machines.

Adtralza contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 150 mg that is to say essentially “sodium-free”.

3. How to use Adtralza

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Each pre-filled syringe contains 150 mg of tralokinumab.

How much Adtralza is given and for how long

• Your doctor will decide how much Adtralza you need and for how long.
• The recommended first dose is 600 mg (four 150 mg injections), followed by 300 mg (two

• 150 mg injections) given every 2 weeks. Based on how well the medicine works, your doctor may decide that you can have a dose every 4 weeks.

Adtralza is given by injection under your skin (subcutaneous injection). You and your doctor or nurse can decide if you caninject Adtralza yourself.

Inject Adtralza yourself only after you have been trained by your doctor or nurse. A caregiver may also give you your Adtralza injection after proper training.

Do not shake the syringe.

Read the “Instructions for Use” before injecting Adtralza.

If you use more Adtralza than you should

If you use more of this medicine than you should or the dose has been given too early, talk to your doctor, pharmacist or nurse.

If you forget to use Adtralza

If you miss injecting a dose at the right time, inject Adtralza as soon as possible. Then the next dose should be injected at the regular scheduled time.

If you stop using Adtralza

Do not stop using Adtralza without speaking to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Adtralza can cause serious side effects, including allergic (hypersensitivity) reactions such as anaphylaxis; the signs may include:

• breathing problems
• swelling of the face, mouth, and tongue
• fainting, dizziness, feeling lightheaded (low blood pressure)
• hives
• itching
• skin rash

Stop using Adtralza and tell your doctor or get medical help immediately if you notice any signs of allergic reaction.

Other side effects

Very common (may affect more than 1 in 10 people)

• upper respiratory tract infections (i.e. common cold and sore throat)

Common (may affect up to 1 in 10 people)

• eye redness and itching
• eye infection
• injection site reactions (i.e. redness, swelling)

Uncommon (may affect up to 1 in 100 people)

• eye inflammation which may cause eye pain or decreased vision

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Adtralza

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Keep in the original package in order to protect from light.

Store in a refrigerator (2 °C to 8 °C). Do not freeze.

If necessary, Adtralza may be kept at room temperature up to 25 °C in the original package for a maximum of 14 days. Do not store above 25 °C. Throw away Adtralza if it is not used within 14 days of storage at room temperature.

If you need to permanently remove the carton from the refrigerator, write down the date of removal on the carton, and use Adtralza within 14 days. Adtralza must not be refrigerated again during this period.

Do not use this medicine if you notice that it is cloudy, discoloured or has particles in it.

Do not throw away any medicines via wastewater or household waste. Ask your doctor, pharmacist or nurse how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Adtralza contains

• – The active substance is tralokinumab.

• – Each pre-filled syringe contains 150 mg of tralokinumab in 1 mL solution for injection.

• – The other ingredients are sodium acetate trihydrate (E262), acetic acid (E260), sodium chloride,

polysorbate 80 (E433) and water for injections.

What Adtralza looks like and contents of the pack

Adtralza is a clear to opalescent, colourless to pale yellow solution, supplied in a glass pre-filled syringe with a needle guard.

Adtralza is available in unit packs containing 2 pre-filled syringes or in multipacks containing 4 (2 packs of 2) or 12 (6 packs of 2) pre-filled syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien	Lietuva
LEO Pharma N.V./S.A	LEO Pharma A/S
Tel/Tel: +32 3 740 7868	Tel: +45 44 94 58 88
Efc^rapufl	Luxembourg/Lu­xemburg
Borola Ltd	LEO Pharma N.V./S.A
Ten.: +359 2 9156 136	Tel/Tel: +32 3 740 7868

Česká republika LEO Pharma s.r.o. Tel: +420 225 992 272	Magyarország LEO Pharma Tel: +36 1 888 0525
Danmark LEO Pharma AB Tlf: +45 70 22 49 11	Malta E.J. Busuttil Ltd Tel: +356 2144 7184
Deutschland LEO Pharma GmbH Tel: +49 6102 2010	Nederland LEO Pharma B.V. Tel: +31 205104141
Eesti LEO Pharma A/S Tel: +45 44 94 58 88	Norge LEO Pharma AS Tlf: +47 22514900
EMáóa LEO Pharmaceutical Hellas S.A. Tql: +30 210 68 34322	Österreich LEO Pharma GmbH Tel: +43 1 503 6979
España Laboratorios LEO Pharma, S.A. Tel: +34 93 221 3366	Polska LEO Pharma Sp. z o.o. Tel.: +48 22 244 18 40
France Laboratoires LEO Tél: +33 1 3014 4000	Portugal LEO Farmacéuticos Lda. Tel: +351 21 711 0760
Hrvatska Remedia d.o.o Tel: +385 1 3778 770	Romania LEO Pharma Romania Tel: +40 213121963
Ireland LEO Laboratories Ltd Tel: +353 (0) 1 490 8924	Slovenija PHARMAGAN d.o.o. Tel: +386 4 2366 700
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika LEO Pharma s.r.o. Tel: +421 2 5939 6236
Italia LEO Pharma S.p.A Tel: +39 06 52625500	Suomi/Finland LEO Pharma Oy Puh/Tel: +358 20 721 8440
Kùnpoç The Star Medicines Importers Co. Ltd. Tql: +357 2537 1056	Sverige LEO Pharma AB Tel: +46 40 3522 00
Latvija LEO Pharma A/S Tel: +45 44 94 58 88	United Kingdom (Northern Ireland) LEO Laboratories Ltd Tel: +44 (0) 1844 347333

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

The Instructions for Use with information about on how to inject Adtralza is shown on the other side of this leaflet.

Instructions for Use

Adtralza

tralokinumab

Solution for injection in pre-filled syringe

Read these instructions before you start using Adtralza pre-filled syringes and each time you get a new package. There may be new information. You should also talk to your healthcare professional about your medical condition or your treatment.

Keep this Instructions for Use so you can read it again if necessary.

Each pre-filled syringe contains 150 mg of tralokinumab.

The Adtralza pre-filled syringes are for single-use only.

IMPORTANT INFORMATION

Important information you need to know before injecting Adtralza:

• Before you inject Adtralza for the first time, your healthcare professional will show you how to prepare and inject Adtralza using the pre-filled syringes.
• Do not inject Adtralza until you have been shown how to inject it the right way.
• Talk to your healthcare professional if you have any questions about how to inject Adtralza the right way.
• To receive your full dose, you will need to have 2 Adtralza injections (1 set of injections). It is recommended that you use a different injection area for each new set of injections.
• The Adtralza pre-filled syringes have a needle guard that will automatically cover the needle after the injection is finished.
• Do not remove the needle cover until just before you give the injection.
• Do not share or reuse your Adtralza pre-filled syringes.

Adtralza pre-filled syringe parts:

Before use After use

How to store Adtralza

• Keep this medicine out of the sight and reach of children.
• Store Adtralza pre-filled syringes in a refrigerator between 2 °C and 8 °C.
• Store Adtralza pre-filled syringes in the original package and protect from light

until you are ready to use them.

• Do not freeze Adtralza pre-filled syringes. Do not use if they have been frozen.
• Adtralza can be stored in the original package at room temperature up to 25 °C for up to

14 days. If removed permanently from the refrigerator, write down the date of removal on the carton, and use Adtralza within 14 days. Discard syringes if left out of the refrigerator for more than 14 days.

Step 1: Setting up Adtralza injection

1a: Gather the supplies needed for your injection

For each Adtralza dose you will need:

• A clean, flat, well-lit work surface, like a table
• Adtralza carton with 2 Adtralza pre-filled syringes
• An alcohol swab (not included in the carton)
• Clean gauze pads or cotton balls (not included in the carton)
• A puncture-resistant sharps disposal container (not included in the carton)

1b: Take the Adtralza pre-filled syringe carton out of the refrigerator

• Check the expiry date (EXP) on the carton. Do not use if the expiry date on the carton has

passed.

• Check to make sure the seal on the Adtralza carton is intact. Do not use the Adtralza pre-filled syringes if the seal on the carton is broken.

Do not use the Adtralza pre-filled syringes if the syringes have been stored at room temperature for more than 14 days.

Waiting time

1c: Let the Adtralza pre-filled syringes reach room temperature

Place the Adtralza carton on the flat surface and wait 30 minutes before you inject Adtralza to let the pre-filled syringes reach room temperature (20 °C to 25 °C). This will help to make injection of Adtralza more comfortable.

Do not heat the pre-filled syringes in any way.

Do not shake the syringes.

Do not remove the needle cover on the pre-filled syringes until you have reached Step 3 and are ready to inject.

Do not put the syringes back in the refrigerator once they have reached room temperature.

1d: Remove the Adtralza pre-filled syringes from the carton

Remove the 2 Adtralza pre-filled syringes one by one from the carton by grasping the body (not the plunger rod) of the Adtralza pre-filled syringes.

• Do not touch the needle guard clips to keep from activating the needle guard too soon.
• Do not remove the needle cover on the pre-filled syringes until you have reached Step 3 and are

ready to inject.

1e: Inspect the 2 Adtralza pre-filled syringes

• Make sure the labels show the correct name of the medicine, Adtralza.
• Check the expiry date on the syringes.
• Check the medicine through the viewing windows. The medicine should be clear to opalescent, colourless to pale yellow.
• Do not use the Adtralza pre-filled syringes if:

o the expiry date on the syringes has passed

o the medicine is cloudy, discoloured, or has particles in it

o the pre-filled syringes look damaged or have been dropped

If you cannot use the syringes, dispose of them in a puncture-resistant container and use new syringes.

• You may see small air bubbles in the liquid. This is normal. You do not need to do anything about it.

Step 2: Choosing and preparing injection area

■ Injection by caregiver only

| Self-injection or injection by caregiver

2a: Choose the area for your injections

• You may inject into:

o your stomach area (abdomen)

o your thighs

o your upper arm. To inject into your upper arm, you will need a caregiver to give you the injections.

• Do not inject where the skin is tender, bruised, scaly, scarred, damaged, hard or covered with eczema.
• Do not inject within 5 cm of your belly button (navel).

2b: Wash your hands and prepare your skin

• Wash your hands with soap and water.
• Clean the injection area for the 2 injections with an alcohol swab using a circular motion.

o Let the area dry completely.

o Do not blow on or touch the cleaned area before injecting.

Step 3: Injecting Adtralza

3a: Pull off the Adtralza needle cover

Hold the Adtralza pre-filled syringe body with one hand, pull the needle cover straight off with your other hand and throw it into the puncture-resistant container.

• Do not try to recap the Adtralza pre-filled syringes.
• Do not hold the plunger rod or plunger head while removing the needle cover.

You may see a drop of liquid at the end of the needle. This is normal.

Do not touch the needle, or let it touch any surface.

3b: Insert the needle

With one hand, gently pinch and hold a fold of skin where you cleaned the injection area. With the other hand, insert the needle completely into your skin at a 45–90 degree angle.

3c: Inject the medicine

Use your thumb to firmly push the plunger head all the way down. All the medicine is injected when you cannot push the plunger head any further.

3d: Release and remove

Lift your thumb off the plunger head. The needle will automatically move back inside the syringe body and lock into place.

• Place a dry cotton ball or gauze pad over the injection area for a few seconds. Do not rub the injection area. If needed, cover the injection area with a small bandage.
• There may be a small amount of blood or liquid where you injected. This is normal.